FDA.reportPublic FDA data

NDC 80425-0413-01 - Quetiapine fumarate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0413
Requested NDC
80425-0413-01
Package NDCs from labels
80425-0413-1, 80425-0413-3, 80425-0413-2, 80425-0413-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-07-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Quetiapine fumarate - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-07-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0413-1Quetiapine fumarate30 in 1 BOTTLETABLET301
80425-0413-2Quetiapine fumarate60 in 1 BOTTLETABLET601
80425-0413-3Quetiapine fumarate90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0413QUETIAPINE FUMARATE TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20240712_1cfc847b-0d8d-fc94-e063-6394a90a311f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0413-1EA - Each80425-0413b2c253ba-9ec4-455e-bb39-dbb03640fca612024-08-12
80425-0413-2EA - Each80425-04135753aa80-8877-41e2-b605-01f83f3a5d9b12024-08-12
80425-0413-3EA - Each80425-04136a9dd31f-d9cf-4b21-9113-c392ebd264dd12024-08-12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 114 · 2,279 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.02b19885-2987-4c46-8d2a-5e59656f72e82026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201109
rxcui: 317174
unii: 2S3PL1B6UJ
QUETIAPINEQUETIAPINEREMEDYREPACK INC.67872105-4ec6-4d46-b3b4-c672c93576d22026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.695415b1-083d-4540-9f41-bde4b201f8342026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201109
rxcui: 312745
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepackc52a9bff-8a03-44f5-9128-799c7dca04672026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack94a81681-381e-4b3b-89ac-e86dcbe7f8902026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201109
rxcui: 312745
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack3eb39b4e-4c79-43b9-a30e-b4221c0e2bd22026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616487
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepackfd9cce28-0052-4b0b-8a66-a1615e082d952026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201109
rxcui: 616487
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINECoupler LLC5643d339-50ea-405d-e063-6394a90a3b702026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201109
rxcui: 312744
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATENorthStar Rx LLCe6e25ef9-2671-489e-8eca-58bedb4f59ab2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
rxcui: 312745
rxcui: 616483
rxcui: 312744
rxcui: 616487
rxcui: 312743
unii: 2S3PL1B6UJ
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
QuetiapineQUETIAPINECoupler LLC56052e5c-0b0b-c296-e063-6394a90a5ad62026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312743
unii: 2S3PL1B6UJ
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Quetiapine fumarateQUETIAPINEUnit Dose Solutions, Inc.55f358e1-9458-b197-e063-6394a90a3f0e2026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201109
rxcui: 317174
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEUnit Dose Solutions, Inc.55f574bc-ec55-93e2-e063-6394a90a1d472026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201109
rxcui: 312744
unii: 2S3PL1B6UJ
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
Quetiapine fumarateQUETIAPINEUnit Dose Solutions, Inc.559fdce5-ab3e-0d02-e063-6394a90a7fbd2026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201109
rxcui: 616487
unii: 2S3PL1B6UJ
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.